FDA recall Z-0065-2020

Product

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771

Reason for recall

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

Distribution

OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland

Key facts

Status

Terminated

Initiation date

2018-11-13

Report date

2019-10-16

Termination date

2020-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0065-2020